Home / Recalls / Merit Medical Systems, Inc. / Z-0137-2023

Z-0137-2023 Class II Ongoing

Recalled by Merit Medical Systems, Inc. — South Jordan, UT

FDA device recall Z-0137-2023 was initiated by Merit Medical Systems, Inc. on Aug 3, 2022 and is designated Class II. Reason for recall: Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in… The recall status is ongoing. Affected quantity: 1822.

Recall Details

Product Type
Devices
Report Date
Nov 2, 2022
Initiation Date
Aug 3, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1822

Product Description

CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B, CORA1825S/A, CORA2010/A, CORA2010/B, CORA2010S/A, CORA2015/A, CORA2015/B, CORA2015S/A, CORA2020/A, CORA2020/B, CORCA1410/A, CORCA1410/B, CORCA1415/A, CORCA1415/B, CORCA1610/A, CORCA1610/B, CORCA1610S/B, CORCA1615/A, CORCA1615/B, CORCA1615S/B, CORCA1810B/A, CORCA1810B/B, CORCA1810SB/A, CORCA1810SB/B, CORCA1815B/A, CORCA1815B/B, CORCA1815SB/A, CORCA1815SB/B, CORCA1820B/A, CORCA1820B/B, CORCA1820SB/A, CORCA1820SB/B, CORCA1825B/A, CORCA1825SB/B, CORCA2010B/A, CORCA2010B/B, CORCA2010SB/A, CORCA2010SB/B, CORCA2015B/A, CORCA2015B/B, CORCA2015SB/A, CORCA2015SB/B, CORCA2020B/A, CORCA2020B/B

Reason for Recall

Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.

Distribution Pattern

Worldwide distribution - US National distribution including in the states of FL, IL, OH, PA, CA, WI, VA, AZ, AR, MS, TN, MO, MA, MI, NY, NE, TX, WA, MN, LA, DE, IN, AL, NJ, OR, MD, GA, CT, OK, UT, KS, NC, CO, KY, WV, AK, NV, RI, SC, ND, NH, MT and the countries of Finland, Denmark, United Arab Emirates, Spain, Sweden, Norway, Jordan, Australia, Germany, Austria, Italy, United Kingdom, France, Canada, Mexico, Puerto Rico, Chile, Reunion, Belgium, Switzerland, Japan, South Africa, Qatar, Russian Federation, Hungary, Thailand, Namibia, Colombia, New Zealand, Netherlands, Saudi Arabia, Costa Rica, Oman, Cyprus, Slovenia, Croatia, China.

Code Information

Catalog Code-Lot/UDI: CORA1610/B-I2075805, I2093969, I2101330, I2124107, I2233501, I2286703, I2325899/00884450476192; CORA1610S/B-I2138037, I2352845/00884450476222; CORA1615/B-H1408433, H1462686, I1863888, I2127448, I2170247, I2259080/00884450476253; CORA1810/A-H1715532, H1756745, H1767115, H1771762, H1776067, H1784861, H1800979, H1808121, H1825693/00884450316405; CORA1810/B-I1781878, I1818817, I1837234, I1843704, I1855418, I1866359, I1952354, I1958525, I1971876, I1990075, I1998862, I2043630, I2070249, I2075810, I2093993, I2114550, I2116110, I2124108, I2127451, I2137798, I2155289, I2206046, I2243065, I2263876, I2263877, I2282032, I2291981, I2297372, I2385808/00884450476116; CORA1810S/B-I1877912, I1877916, I1902603, I1971867, I1998851, I2033178, I2070341, I2075809, I2124109, I2127455, I2170248, I2370120/00884450477625; CORA1815/A-H1733631, H1734003, H1739133, H1756746, H1771770, H1795481, H1800980, H1807701/00884450316412; CORA1815/B-I1821113, I1838444, I1855417, I1920169, I1920191, I1946564, I1952362, I1989173, I1990074, I2033176, I2070349, I2075808, I2093995, I2114555, I2116111, I2124110, I2127456, I2137805, I2170249, I2201366, I2233502, I2263885, I2269827, I2325901, I2349440/00884450477618; CORA1815S/A-H1756747, H1784863/00884450316528; CORA1815S/B-I1869477, I1874063, I2075806, I2114557, I2127463, I2325902/00884450477601; CORA1820/A-H1375632, H1382959, H1718587, H1734004, H1739135, H1756748, H1762731, H1771773, H1771881, H1784864, H1815597/00884450316429; CORA1820/B-I1823060, I1971866, I2114564, I2137809, I2170250, I2303053, I2385809/00884450477595; CORA1820S/A-H1739136, H1790841/00884450316535; CORA1825/A-H1749790, H1762724, H1808022, H1815598/00884450316436; CORA1825/B-I1843706, I1958504, I2234738, I2239042/00884450477571; CORA1825S/A-H1790845/00884450316542; CORA2010/A-H1784872, H1815600/00884450316443; CORA2010/B-I1863885, I2201378, I2206047, I2237417/00884450477557; CORA2010S/A-H1692834, H1776070/00884450316559; CORA2015/A-H1795483/00884450316450; CORA2015/B-I1823512, I1860367, I1962715, I2140223, I2243072, I2283710, I2303054, I2330668/00884450477526; CORA2015S/A-H1697709, H1771823, H1784884, H1795484/00884450316566; CORA2020/A-H1815606/00884450316467; CORA2020/B-I1781880, I1971845, I2007291, I2228365/00884450477496; CORCA1410/A-H1639707/00884450316580; CORCA1410/B-I2244480, I2384730/00884450476284; CORCA1415/A-, H1776075/00884450316597; CORCA1415/B-I2191846, I2286700, I2318838, I2325906/00884450476314; CORCA1610/A-H1428538, H1714401/00884450316603; CORCA1610/B-I1971855, I1998714, I2114620, I2170251, I2201382, I2233505, I2318858, I2343154/00884450476338; CORCA1610S/B-I1874064, I2010416/00884450476345; CORCA1615/A-H1703701/00884450316610; CORCA1615/B-I1845903, I1888547, I1920175, I1962716, I1998860, I2103685, I2137221, I2137223, I2170252, I2237426, I2286696, I2297374, I2303056, I2330680, I2385810/00884450476352; CORCA1615S/B-I2114626, I2246748/00884450476369; CORCA1810B/A-H1718595, H1734012, H1749798, H1756750, H1771846, H1776080, H1782158, H1790850, H1800985, H1808042/00884450316627; CORCA1810B/B-I1814729, I1838323, I1843705, I1845904, I1869474, I1877911, I1888548, I1902611, I1920161, I1946561, I1946566, I1958530, I1962714, I1990098, I1990104, I1998856, I2025072, I2070266, I2070374, I2093853, I2101369, I2104884, I2114628, I2114714, I2114715, I2116109, I2124195, I2127511, I2150947, I2150948, I2150949, I2159264, I2165513, I2165514, I2201386, I2221444, I2286695, I2303061, I2330685, I2343157, I2385811/00884450476376; CORCA1810SB/A-H1733634, H1800986/00884450316801; CORCA1810SB/B-I1862927, I1920180, I2033140, I2114634, I2233507, I2303065, I2330686/00884450476383; CORCA1815B/A-H1476238, H1608916, H1714408, H1734014, H1734016, H1743880, H1749800, H1749802, H1762717, H1771848, H1776082, H1782159, H1790847, H1795487, H1807720/00884450316634; CORCA1815B/B-I1827256, I1838326, I1843709, I1845905, I1860329, I1860365, I1877914, I1888549, I1902608, I1902609, I1920165, I1920186, I1946560, I1946567, I1952368, I1958533, I1962702, I1971860, I1971861, I1990097, I1990103, I2007293, I2058398, I2061959, I2062021, I2065393, I2075813, I2075839, I2094063, I2098053, I2102664, I2105077, I2114651, I2114652, I2124197, I2127514, I2127515, I2150950, I2150952, I2159275, I2159276, I2170253, I2201393, I2217616, I2281931, I2318869, I2330533, I2330692, I2336279, I2343163, I2349439, I2357134, I2385813, I2385814/00884450476390; CORCA1815SB/A-H1714409, H1743881, H1756752, H1762715/00884450316740; CORCA1815SB/B-I1838328, I1845906, I1877918, I1958536, I2061956, I2075811, I2093850, I2094072, I2233509, I2325909, I2330694, I2399997/00884450476406; CORCA1820B/A-H1718598, H1733635, H1734019, H1749803, H1756754, H1762714, H1771883, H1776084, H1790851, H1807721/00884450316641; CORCA1820B/B-I1827257, I1845907, I1902605, I1902607, I1920166, I1946562, I1971929, I1990094, I1998850, I1998858, I2007294, I2094075, I2103689, I2114708, I2124200, I2127516, I2150980, I2159282, I2159283, I2233510, I2286679, I2343166, I2352856/00884450476413; CORCA1820SB/A-H1733637/00884450316757; CORCA1820SB/B-I2137856, I2325911/00884450476437; CORCA1825B/A-H1718603/00884450316658; CORCA1825B/B-I1946563, I2137863, I2201410, I2265757, I2325913/00884450476451; CORCA1825SB/B-I2156607/00884450476468; CORCA2010B/A-H1445217, H1703705, H1708690, H1718606, H1718607, H1749806, H1762738, H1771884, H1807725, H1815614/00884450316665; CORCA2010B/B-I18210937/I1845908, I1862929, I1874055, I1877913, I1958538, I1971927, I1990070, I2075817, I2094080, I2114709, I2127519, I2170256, I2217622, I2325922/00884450476475; CORCA2010SB/A-H1749807/00884450316771; CORCA2010SB/B-I1874058, I1902604, I1998852, I2122957, I2233511/00884450477632; CORCA2015B/A-H1624841, H1639711, H1657959, H1697713, H1708691, H1714416, H1718609, H1733639, H1734020, H1743882, H1749810, H1771851, H1776086, H1784915, H1790853, H1807727/00884450316672; CORCA2015B/B-I1827258, I1855420, I1862900, I1873128, I1874060, I1888545, I1902614, I1920156, I1952374, I1990072, I1998863, I2070355, I2080473, I2094083, I2114711, I2116112, I2124201, I2127521, I2137868, I2159284, I2191857, I2246760, I2263980, I2287299, I2303068, I2352880, I2370145/00884450477649; CORCA2015SB/A-H1662694, H1733642, H1739148, H1771853, H1776087, H1807729, H1815615/00884450316788; CORCA2015SB/B-I1827270, I1845912, I1862899, I2080472, I2170257, I2201414/00884450477656; CORCA2020B/A-H1662697, H1692861, H1708693, H1718613, H1756755, H1771854, H1776088, H1790855, H1807731/00884450316689; CORCA2020B/B, I1827272, I1845913, I1869475, I1874065, I1877915, I1971882, I1990071, I2070361, I2075814, I2114712, I2151307, I2170259, I2201416, I2330716/00884450477663; CORCA2020SB/B-I2263985, I2297377/00884450477670;

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0137-2023
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources